RE: Evening all14 Feb 2021 22:24
Dallo,
The language used was very politically correct ....
No Spa but we have a clear regulatory pathway ...
The clear regulatory pathway is known to all , it’s FDA guidance on all SLE trials :-)
It’s basically what I have being saying for a long time ...
Avion asked the FDA to change their guidelines in some way , but the FDA after all this time , have said
´ no changes , guys ´.
This is of course only my opinion ....